COMMUNITY HEALTH
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Health Alerts
CDC: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - 2011/2012 Flu Season
August 29, 2011
FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene
11-19-2010
The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has requested that companies voluntarily withdraw propoxyphene from the United States market.
Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. It is sold under various names as a single-ingredient product (e.g., Darvon) and as part of a combination product with acetaminophen (e.g., Darvocet).
FDA’s recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary below). The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms. FDA has concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses.
Click here for more information from the FDA
Methicillin-Resistant Staphylococcus Aureus (MRSA) Community-Acquired Pneumonia Associated with Influenza, Allegheny County
March 6, 2009
The Pennsylvania Department of Health (PADOH) is releasing the following updated information regarding recent, influenza-associated deaths in two young adults, ages 21 and 25, from Allegheny County. In both instances, influenza illness was complicated by a rapidly progressive pneumonia caused by community-associated methicillin-resistant Staphylococcus aureus (MRSA). There is no information on their immunization status. In recent years, severe MRSA pneumonia associated with influenza has been increasingly recognized in the United States
Although uncommon, MRSA Community-Acquired Pneumonia (CAP) has few, obvious characteristics that differentiate it from other bacterial infections or from influenza virus infection alone; MRSA CAP often affects young, otherwise healthy persons and can be fulminant and rapidly fatal. MRSA should be suspected in persons with severe pneumonia, especially during the influenza season, in those with cavitary infiltrates, and in those with a history of MRSA infection. Individuals with influenza associated bacterial infections may require broad, initial, antibiotic coverage that includes coverage for MRSA until culture and sensitivities are known. Please report fatal cases of MRSA CAP or cases requiring hospitalization or ICU admission to your local health department or to the Pennsylvania Department of Health at 1-877-PA-HEALTH.
Click here for more information from PA Department of Health
Metoclopramide-Containing Drugs (Reglan)
February 26, 2009
FDA notified healthcare professionals that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. These symptoms are rarely reversible and there is no known treatment. Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. Manufacturers will be required to implement a risk evaluation and mitigation strategy [REMS] to ensure patients are provided with a medication guide that discusses this risk. Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment.
[February 26, 2009 - News Release - FDA]
Novovirus
January 28, 2009
The Pennsylvania Department of Health (DOH) issued a health advisory about a higher than normal number of people getting sick with Norovirus this winter. People with Norovirus illnesses have been identified both in the community and in hospitals and nursing homes. Below is some information about Norovirus that can be used to prevent the disease.
What is Norovirus?
Norovirus is a stomach or GI virus that causes upset stomach, vomiting, and diarrhea. Vomiting seems to be more common in people with Norovirus than other GI viruses. People with Norovirus infections can also have muscle aches and fever. Usually the illness is mild, with GI symptoms lasting only a few days, but tiredness that may last a few more days.
Click here For more information from the PA Department of Health
Singulair - Possible mood changes
January 13, 2009
[UPDATE 01/13/2009] FDA provided updated information to its March 2008 Early Communication. FDA is continuing to review clinical trial data to assess other neuropsychiatric events, (mood and behavioral adverse events) related to drugs that act through the leukotriene pathway (montelukast, zafirlukast, zileuton). As a result, FDA has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events associated with montelukast, zafirlukast, and zileuton.
[Posted 03/27/2008] FDA informed healthcare professionals and patients of the Agency's investigation of the possible association between the use of Singulair and behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma. Patients should not stop taking Singulair before talking to their doctor if they have questions about the new information. Healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. Due to the complexity of the analyses, FDA anticipates that it may take up to 9 months to complete the ongoing evaluations. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
[January 13, 2009 -
Follow-up to the March 27, 2008 Communication
-
FDA]
[March 27, 2008 -
Early Communication About an Ongoing Safety Review
- FDA]
RECALL ALERT
Nationwide recall of all strengths of Digitek (digoxin tablets, USP)
April 30, 2008
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions. You can find more information on the Actavis Totowa website.
Measles outbreaks in the United States: Public health preparedness, control and response in healthcare settings and the community
April 2, 2008
A measles outbreak linked to an importation from Switzerland currently is ongoing in Arizona. The first case, with rash onset on February 12, 2008, occurred in an adult visitor from Switzerland who was hospitalized with measles and pneumonia. This hospital admission prompted verification of the measles immune status of approximately 1800 healthcare personnel and vaccination of those without evidence of immunity. Through March 31, 2008, nine confirmed cases have been reported to the Arizona Department of Health Services, and there are two suspected cases (one in a Colorado resident) and hundreds of contacts under investigation. The nine case-patients range in age from 10 months to 50 years. All but one were infected in healthcare settings, one of the five adult case-patients is a healthcare worker, and all cases were unvaccinated at the time of exposure.
Preventing transmission in healthcare settings
To prevent transmission of measles in healthcare settings, airborne infection control precautions (available at http://www.cdc.gov/ncidod/dhqp/gl_isolation.html should be followed stringently.
Further information on measles and measles vaccine is available at state health departments’ websites and at http://www.cdc.gov/vaccines/vpd-vac/measles/default.htm.
RECALL ALERT
PRICARA™ Recalls 25 mcg/hr Duragesic® (fentanyl transdermal system) CII Pain Patches
February 12, 2008
PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.
Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.
Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.
Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.
Patients using fentanyl patches who have medical questions should contact their health-care providers.
For more information, visit http://www.duragesic/. com.
EXPANDED RECALL ALERT
Am2Pat, Sierra Pre-filled and B. Braun prefilled heparin and saline flush syringes
January 18, 2008
The Pennsylvania Department of Health (PADOH) is releasing the following information regarding the Expanded Recall Alert for Am2Pat, Sierra pre-filled and B. Braun prefilled heparin and saline flush syringes:
CDC has notified state health departments that Am2Pat intends to extend the recall of prefilled heparin and saline flush syringes to encompass all distributed lots of these products because of concerns these syringes may be contaminated with Serratia marcescens.
On December 20, 2007, Am2Pat recalled one lot of prefilled heparin flush syringes –(
http://www.fda.gov/oc/po/firmrecalls/am2pat12_07.html
)
CDC has been informed that the updated recall will now apply to ALL prefilled heparin and saline flush syringes made by Am2Pat.
These syringes were manufactured by Am2Pat and may be labeled as: Am2Pat, Sierra Pre-filled, or B. Braun. These products will all bear the National Drug Code or NDC prefix of: 64054.
They have been distributed to in-patient and out-patient facilities and directly to patients by home-care companies.
Patients and clinicians should immediately stop using these products. Persons who have questions regarding the manufacturer of prefilled syringes they are using should call the supply company that provided the syringes.
Healthcare practitioners identifying cases of Serratia bloodstream infections among patients who might have been exposed to these products should report these to their local health department.
Local health departments identifying cases of Serratia bloodstream infections potentially related to the recalled products are asked to report the information to their state health departments.
Chantix (Varenicline)
FDA Reviewing Post Marketing Cases Describing Suicidal Ideation An d Occasional Suicidal Behavior
November 20, 2007
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.
Read the complete 2007 MedWatch safety summary including a link to the FDA Early Communication Sheet about an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix.
FDA Issues Safety Alert on Avandia
May 21, 2007
The U.S. Food and Drug Administration (FDA) is aware of a potential safety issue related to Avandia (rosiglitazone), a drug approved to treat type 2 diabetes. Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia. However, other published and unpublished data from long-term clinical trials of Avandia, including reanalyses of data from DREAM (a previously conducted placebo-controlled, randomized trial) provide contradictory evidence about the riskd in patients treated with Avandia.
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
To see a list of Health Alerts in our archives, click here.
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